FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: LUMINOS Lotus Max (VF11)
- Recall number
- Z-1481-2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- LUMINOS Lotus Max (VF11)
- Status
- Open, Classified
- Initiated
- 2022-11-23
- Posted
- 2023-05-23
- Terminated
- not on file
- Reason
- Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Siemens Medical Solutions USA, Inc., will provide software updates to the affected systems with software versions VF10 and VF11 with software via Update Instructions (UI) XP007/23/S, XP004/23/S, XP003/23/S, and XP001/23/S
- Quantity
- 704 units in the United States (1945 units worldwide)
- Distribution
- US Nationwide - Worldwide Distribution
- Lot, serial or model codes
- Model: 11574100
- 510(k) numbers
- ["K173639"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28